Cytokines, Gastric Adenocarcinoma, Gastric Cancer, Microbiome, Nutritional Status
Conditions
Keywords
Gastric Cancer, Microbiome, Nutritional Status, Cytokines
Brief summary
The objective of this randomized controlled, prospective clinical study, composed of 5 groups, G1, G2, G3, G4 and G5 is \[Evaluate the intestinal microbiota profile, nutritional, immunological status and inflammatory profile, before and after total or partial removal surgery (gastrectomies) for gastric cancer, in a patient using probiotic supplements.\] The main questions it aims to answer are: * probiotics are capable of modulating the immune response and microbiota in cancer patients who will undergo surgery * surgery itself alters the immunological pattern and microbiota of cancer patients Participants will be divided into groups for evaluation and the G1 intervention group will take probiotic capsules. The researchers will compare groups G1, G2 with G3 (negative control group) to see if there are differences between using probiotics or not, in controlling the immune response and if there are significant changes in their intestinal microbiota. Groups G4 and G5 will also be compared, where in these we will only measure the power of the use of probiotics in reducing surgical complications in the postoperative period.
Interventions
DIETARY_SUPPLEMENTFormulation with probiotics
Lactobacillus acidophilus NCFM®, Lactobacillus paracasei Lpc-37 ™, Bifidobacterium lactis Bi-04™, Bifidobacterium lactis Bi-07™, Bifidobacterium bifidum Bb-02™)
OTHERNon-intervention for Clinical Outcomes -G5
only observation of clinical outcomes in the postoperative period
Sponsors
Universidade Federal do Amazonas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
For the first stage of the research, patients eligible for cancer gastrectomies were invited at FCECON on an outpatient basis or through the surgical map on the day of admission. Randomization took place through a specific application called Randomizer for Clinical Trial Lite. Different wards were assigned to each group to avoid contact between research participants (G1 intervention and G2 non-intervention). For the G3 (control) group, they will be recruited by invitation, they must be FCECON employees, this group will specifically be matched by the socioeconomic level of the patients in the G1 group. The G4 and G5 groups will be recruited and randomized in the second stage of the research after the end of the collection of the G1 and G2 groups, for analysis of clinical outcomes in the 7-day postoperative period.
Intervention model description
In time 1 of the research, patients will be distributed through the Randomizer Clinical Trial Lite application into 4 groups (G1, G2, G4 and G5) to receive 1 capsule a day of probiotics (groups G1 and G4) will receive a formulation containing 20 billion of microorganisms. In group G2 (no intervention), treatment with standard nutrition, without the use of probiotics. The intervention product (probiotic capsules) will be distributed and packaged according to randomization for blinding. In the case of group G3 (control), they will receive probiotic capsules after the end of groups G1 and G2. Both groups that will use probiotic capsules, 1 capsule per day, in the same shift, must continue for 7 days, without interruption in monitoring. In relation to groups G4 and G5, they constitute time 2 of the research, with G4 being the group that will use probiotics following the G1 standard and G5 will use placebo capsules with 0.5g of calcium carbonate to test the power of the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with indication for total or partial gastrectomy; * Ages from 18 years old.
Exclusion criteria
* Palliative patients * Use of probiotics and prebiotics in the last 15 days; * Patients who are unable to complete all monitoring steps; * AIDS patients; * Diabetic patients; * Pregnant patients; * Patients with Autoimmune Diseases; * Patients with Liver Diseases; * Patients with Kidney Disease; * Patients with Inflammatory Bowel Diseases. * Patients who have MCP (pacemaker), * Patients with severe Edema, * Patients with titanium plates in any limb of the body * Patients who for some reason had their surgeries suspended during follow-up. * Patients undergoing mechanical colon preparation in the last 30 days. * Patients not resident/domiciled in Amazonas.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modulation of the Immune Response | twelve months | We will measure (measure the concentration) of inflammatory cytokines through flow cytometry, and then observe whether the intervention interferes negatively or positively in the inflammatory pattern. |
| Modulation of the Intestinal Microbiota | twelve months | The use of probiotics positively interfered in maintaining a change in the pre-surgical microbial profile, in relation to the post-surgical one. |
| The use of probiotics can modify the incidence of postoperative complications | twelve months | During surgery, many inflammatory factors can interfere with the appearance of postoperative complications. We assume that the use of probiotics can beneficially modulate surgical complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modulation of nutritional parameters with the use of probiotics-weight and height | twelve months | Nutritional measurements such as weight and height will be combined to obtain BMI and evaluate body mass, as biological markers that can be modulated with the use of probiotics. |
| Modulation of nutritional parameters using probiotics-phase angle | twelve months | Nutritional measurements such as phase angle (a measurement obtained by applying electrical bioimpendance, as a biological marker that can be modulated with the use of probiotics |
Countries
Brazil
Outcome results
None listed